Palm Beach, FL – November 11, 2020 – Academia and industry around the world are working from basic research to advanced technology to alleviate the effects of the COVID‐19 health crisis. The application of nanoscience and nanotechnology concepts and tools is a good approach within the current global priority. Nanomedicine may provide the fastest-track to the multitude of health issues that are embodied in the global pandemic. Nanotechnology is a common term for nanoscale science, engineering and technology, which offers extraordinary economic and technological benefits. Healthcare is one of the most prominent field of research in nanotechnology. Nanomedicine can be understood as a field of diagnosing, treating and preventing disease using molecular tools and knowledge of the human body. Nanomedicine can address many essential medical problems by using nanomaterials and by obtaining clarity on their interaction with biological systems. Nanomedicine products have various potential applications such as in drug delivery, in vivo imaging, in vitro diagnostics, regenerative medicine, dental, medical devices, and dermal applications. Researchers are turning to nanotechnology to look for answers. Active Biotechs in the markets today include: NanoViricides, Inc. (NYSE: NNVC), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Altimmune, Inc. (NASDAQ: ALT), Eli Lilly and Company’s (NYSE: LLY), Pfizer Inc. (NYSE: PFE).
One industry publication (IOPScience) during a report focused on nanotechnology said: “The novel coronavirus pneumonia pandemic was declared as ‘public-health emergency of international concern’ by the World Health Organization on 30 January 2020. The sudden emergence… has triggered alarm for… instant management using anti-viral measures and diagnostic tools… Taking into consideration the current severity of this disease and the imperative need of SARS-CoV-2 specific treatment and diagnostic tools, nanotechnology-based approaches can provide promising alternatives to conventional ways of disease diagnosis, treatment, and preventing exposure to SARS-CoV-2.”
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: NanoViricides Has Engaged Calvert Labs for Safety Pharmacology Studies of Its Drug for the Treatment of COVID-19 – NanoViricides, a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today reported that it has engaged Calvert Labs, a contract research organization (“CRO”), for performing the Safety Pharmacology studies of its clinical drug candidate for the treatment of COVID-19.
The Company has been diligently working on advancing its drug candidates for the treatment of COVID-19 towards human clinical trials as rapidly as feasible.
The Company intends to perform certain core safety pharmacology studies to ensure safety of the drug candidates at Calvert Labs. The data from these studies will be used for filing an IND application. Prior to that, the Company also intends to file a pre-IND application with the U.S. Food and Drug Administration (“FDA”) to obtain guidance.
The recent increase in COVID-19 cases worldwide has led scientists to suggest that this pandemic virus is expected to become a circulating virus. Influenza viruses and common cold viruses are other examples of circulating viruses. However, SARS-CoV-2 is more virulent, and thereby causes substantially greater morbidity and mortality than these other circulating viruses. Therefore, development of an effective drug to treat the disease caused by SARS-CoV-2 is very important.
A curative treatment for a virus such as SARS-CoV-2 coronavirus would require a multi-faceted attack that shuts down (i) the ability of the virus to infect host cells and simultaneously and (ii) the ability of the virus to multiply inside the host cells. The nanoviricide® platform enables direct multi-point attack on the virus that is designed to disable the virus and its ability to infect new cells. At the same time, a nanoviricide is also capable of carrying payload in its “belly” (inside the micelle) that can be chosen to affect the ability of the virus to replicate. The nanoviricide is designed to protect the payload from metabolism in circulation. Thus, the nanoviricide platform provides an important opportunity to develop a curative treatment against SARS-CoV-2, the cause of COVID-19 spectrum of pathologies. Read the full press release by going to: http://www.nanoviricides.com/companynews.html
In other biotech news in the markets this week:
INOVIO (NASDAQ:INO) a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, this week reported financial results for the quarter ended September 30, 2020. INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Standard Time today to discuss financial results and provide a general business update, including near-term expectations for its COVID-19 DNA vaccine development program and a clinical program update for its DNA medicines portfolio. The live webcast and a replay may be accessed by visiting INOVIO’s website at http://ir.inovio.com/events-and-presentations/default.aspx.
Altimmune, Inc. (NASDAQ: ALT), a clinical-stage biopharmaceutical company, recently announced that it entered into an agreement with Lonza for the manufacturing of AdCOVID™, Altimmune’s next-generation, single-dose intranasal vaccine candidate for COVID-19. Lonza is a leading global biopharmaceutical manufacturing company with facilities in Europe, North America, and South Asia.
Alberto Santagostino, SVP, Head of Cell and Gene Technologies for Lonza, commented, “We are deeply committed to fighting this global pandemic and deploying our expertise and resources to help vaccine developers like Altimmune meet commercial manufacturing requirements for novel and promising vaccine candidates. Lonza is proud to be well-positioned to support these companies in their mission to serve such critical public health needs.”
The U.S. Food and Drug Administration (FDA) recently granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (BNTX) this week announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose.
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